Today, Neuralink officially began searching for a patient for its first-in-human clinical trial. The company is looking for patients with quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) to enter this trial. The aim of the trial is to test ways to restore full body movement.
Here’s what the company wrote about this in the official blog post.
“We are happy to announce that we’ve received approval from the independent institutional review board and our first hospital site to begin recruitment for our first-in-human clinical trial. The PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface) – a groundbreaking investigational medical device trial for our fully implantable, wireless brain-computer interface (BCI) – aims to evaluate the safety of our implant (N1) and surgical robot (R1) and assess the initial functionality of our BCI for enabling people with paralysis to control external devices with their thoughts.
During the study, the R1 Robot will be used to surgically place the N1 Implant’s ultra-fine and flexible threads in a region of the brain that controls movement intention. Once in place, the N1 Implant is cosmetically invisible and is intended to record and transmit brain signals wirelessly to an app that decodes movement intention. The initial goal of our BCI is to grant people the ability to control a computer cursor or keyboard using their thoughts alone.
The PRIME Study is being conducted under the investigational device exemption (IDE) awarded by the FDA in May 2023 and represents an important step in our mission to create a generalized brain interface to restore autonomy to those with unmet medical needs.
Those who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify. ”
(source – Neuralink)